Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147388
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-15
Brief Title:
Regression of Cervical Precancerous Lesions and Associated Risk Factors
Sponsor:
General University Hospital Prague
Organization:
General University Hospital Prague
Study Overview
Official Title:
Regression of Cervical Precancerous Lesions and Associated Risk Factors
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECER
Brief Summary:
The aim of this study is to assess the extent of histopathological regression of severe cervical precancerous lesions CIN 2 and CIN 3 evaluate the proportion of patients who experience the normalization of HPV test and cytology finding among those who were treated conservatively and those who underwent conization and identify predictive parameters associated with regression Based on this analysis a model will be proposed to predict the likelihood of lesion regression
Detailed Description:
Introduction There are three grades of dysplasia of the cervix based on their severity CIN 1-3 Most women with CIN 2 or CIN 3 high-grade - HG lesions are referred for conization due to the presumed risk of developing invasive cervical cancer However this surgical intervention is associated with an increased risk of preterm labor in the future
From the literature it is evident that 30 - 60 of CIN 2 and CIN 3 lesions spontaneously regress Colposcopic examination is a tool that can accurately assess the severity of the lesion and safely evaluate the dynamics of its development It can be used to exclude the presence of invasive cervical cancer
The aim of the study is to determine the absolute rate of spontaneous regression of HG lesions considering stratification factors
Methods Patients meeting all inclusion criteria and none of the exclusion criteria are included see below Colposcopic evaluations occur at four-month intervals during the study In case of progression the patient is indicated for conization in case of persistence the patient is consulted and can choose further observation or conization in case of regression punch biopsy is performed to acquire a histopathologic sample for primary endpoint evaluation The biopsyconization result is subsequently compared with the initial sample to declare regression or persistence of the HG lesion
The HPV status and cytological findings are evaluated similarly Stratification criteria such as age colposcopic characteristics HPV genotype Cobas 4800 Roche Molecular Systems Pleasanton USA methylation markers GynTect Oncgnostics GmbH Löbstedter Str 41 07749 Jena Germany semiquantitative microscopic assessment of the vaginal swab and personal history are assessed during monitoring
From the literature it is evident that 30 - 60 of CIN 2 and CIN 3 lesions spontaneously regress Colposcopic examination is a tool that can accurately assess the severity of the lesion and safely evaluate the dynamics of its development It can be used to exclude the presence of invasive cervical cancer
The aim of the study is to determine the absolute rate of spontaneous regression of HG lesions considering stratification factors
Methods Patients meeting all inclusion criteria and none of the exclusion criteria are included see below Colposcopic evaluations occur at four-month intervals during the study In case of progression the patient is indicated for conization in case of persistence the patient is consulted and can choose further observation or conization in case of regression punch biopsy is performed to acquire a histopathologic sample for primary endpoint evaluation The biopsyconization result is subsequently compared with the initial sample to declare regression or persistence of the HG lesion
The HPV status and cytological findings are evaluated similarly Stratification criteria such as age colposcopic characteristics HPV genotype Cobas 4800 Roche Molecular Systems Pleasanton USA methylation markers GynTect Oncgnostics GmbH Löbstedter Str 41 07749 Jena Germany semiquantitative microscopic assessment of the vaginal swab and personal history are assessed during monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None